This invention relates to a flexible container for materials which are normally incompatible when mixed together and stored. More particularly, this invention relates to a compartmented container wherein two incompatible materials can be sterilized in the flexible container and can subsequently be readily intermixed and administered in a safe and convenient manner.
Compartmented containers for different types of materials are well known in the art. For example, in U.S. Pat. No. 3,608,709 a laminated package is provided with an intermediate seal which includes a release area to allow the two materials to intermix. In U.S. Pat. No. 3,964,604 a rupturable seam barrier is disclosed in a laminated multi-compartmented container for a similar purpose. U.S. Pat. Nos. 3,674,134 and 3,750,907 also illustrate rupturable seals in multi-layered packages, with U.S. Pat. No. 3,674,134 depicting an intermediate or inhibiting layer between two other layers for delamination purposes and U.S. Pat. No. 3,750,907 illustrates a foil and resin lamination and the use of processing conditions to produce strong and weak seal portions.
The prior art does not provide a multi-compartmented container for internally intermixing an intravenous solution which can be readily sterilized yet activated in a desired manner. In the manufacture of containers in the health care field a primary consideration is the sterility of the contents. In the prior art containers there are inherent deficiencies that either prevent them from being produced economically, fail to be fabricated and function as desired, or neglect to meet all end-user requirements, including sterility.
It is an advantage of the present invention to provide a container separated into two compartments containing two components that would be intermixed at the time of use by means of rupturing an internal frangible member to allow the separated components to completely intermix with each other. Other advantages are a flexible intravenous solution container containing parenteral intravenous products to be intermixed and subsequently administered; a multi-compartmented container having a delaminated seal member separating the compartments wherein the means of rupturing the seal separating the two compartments can be consistently controlled; a multi-compartmented container that is simple in design and able to be mass produced using existing technology, commonly used fabrication equipment and applicable to a wide range of materials; a container which provides a method of intermixing at least two I.V. components, so that when they are combined, maintenance of sterility is assured; and a method of combining two separated components for an admixture solution that is not time consuming, does not require special facilities, or highly trained personnel to activate.